HPLC法测定咳特灵胶囊中马来酸氯苯那敏的含量及含量均匀度

目的建立用HPLC法测定咳特灵胶囊中马来酸氯苯那敏的含量及含量均匀度。方法采用Gemini C18（250mm×4．6mm，5μm）色谱柱，检测波长226，1m，甲醇-庚烷磺酸钠醋酸溶液（取庚烷磺酸钠2．0g，加冰醋酸10ml，用水稀释至400ml）（60：40）为流动相，流速为1．0ml·min^-1。外标法测定含量。结果精密度及回收率结果良好，平均回收率为98．6％（n=5），RSD：2．0％。结论方法准确可靠，可用于咳特灵胶囊中马来酸氯苯那敏的含量及含量均匀度的测定.

Determination of content and content uniformity of chlorphenamine maleate in Keteling capsules by HPLC

Aim To develop an HPLC method for determination of content and content uniformity of chlorphenamine maleate in Keteling capsules.Methods A Gemini C18 column(250 mm×4.6 mm,5 μm) was adopted with a mixure of methanol and N-heptane solution of sodium acetate(sodium heptane 2.0 g,added with glacial acetic acid 10 ml,diluted to 400 ml with water)(60∶40) as mobile phase.The flow rate was 1.0 ml·min-1 and the UV detection wavelength was set at 226 nm,and content was calculated by external standard method.Results The average recovery was 98.6%,and RSD was 2.0%.Conclusions This method is reliable,accurate and suitable for the determination of content and content uniformity of chlorphenamine maleate in Keteling capsules.